DynaCirc CR Once-Daily Calcium Channel Blocker Launched
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DynaCirc CR Once-Daily Calcium Channel Blocker Launched

EAST HANOVER, N.J., Feb. 10, 1997 -- Novartis Pharmaceuticals Corporation has added DynaCirc CR, a once-a-day calcium channel blocker, to its anti-hypertension product line. Developed by Sandoz Research in collaboration with ALZA Corporation, DynaCirc CR is available in 5 mg and 10 mg controlled release tablets. The new formulation is Novartis' first launch of a line extension and offers continuous reduction of blood pressure throughout a 24 hour period.

Demonstrated to be safe in a broad range of patients, including elderly(1), renally impaired and diabetic patients(2-5), as well as patients with underlying cardiovascular conditions(2,6), isradipine, the active ingredient in DynaCirc CR, is a potent intermediate-acting dihydropyridine calcium antagonist. Since being introduced to the U.S. in 1991, DynaCirc (isradipine) has been prescribed for more than three million patients. Two meta-analyses performed during 1995 and 1996 evaluated more than 11,000 patients in 70 clinical trials and confirmed the compound's safety when used as indicated.

DynaCirc CR achieves its once-a-day dosing regimen through the use of osmotic controlled release technology developed by ALZA Corporation in Palo Alto, California. Known as OROS(R), OSMOTIC THERAPEUTIC SYSTEM, the system is based on a semipermeable membrane surrounding an osmotically active core. The core is composed of two layers, an "active" layer containing the drug and a pharmacologically inert, but osmotically active, "push" layer.

After ingestion, the tablet overcoating is quickly dissipated in the gastrointestinal tract allowing water to enter the tablet through the semipermeable membrane. The polyethylene oxide polymer swells in the osmotic "push" layer and expands against the "active" drug layer releasing an essentially constant dose of isradipine as a fine suspension.

ALZA Corporation is a leader in the development and commercialization of innovative pharmaceutical products using advanced delivery technologies to add medical and economic value to drug therapies.

Novartis Pharmaceuticals Corporation researches and develops, manufactures and markets leading innovative prescription drugs used to treat a number of diseases and conditions, including organ transplantation, cardiovascular diseases, schizophrenia, cancer, epilepsy and arthritis. As a result of the merger, Novartis Pharmaceuticals in the U.S. is now part of the second largest pharmaceutical company in the world.

References

(1) Cohen JD, Carr AA, Blecker D, et al. DYNAMICS trial of isradipine in hypertension with and without coexisting diseases. Clin Geriatr. 1994;2:36-52.

(2) Marcus AO, Antihypertensive therapy with the calcium channel blocker isradipine; an appropriate choice for the diabetic patient with hypertension, Review. Curr Ther Res, 1993;54:763-778.

(3) Berg KJ, Holdaas H, Endresen L, et al. Effects of isradipine on renal function in cyclosporin-treated renal transplanted patients. Nephrol Dial Transplant. 1991;6:725-730.

(4) Francischetti EA, de Silva IB, Fagundes VG. Effects of long-term administration of isradipine on renal hemodynamics and sodium metabolism. J Cardiovasc Pharmacol. 1992; 19 (supp 3):S90-92.

(5) Persson B, Andersson OK, Wysocki M, et al. Renal and hemodynamic effects of isradipine in essential hypertension. Am J Med, 1989;86 (supp 4A):60-64.

(6) Grossman E, Messerli FH, Oren S, et al. Cardiosvascular effects of isradipine in essential hypertension. Am J Cardiol. 1991;68:65-70

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